MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-15 for MALLET N/A UNKNOWN MALLET manufactured by Biomet Orthopedics.
[20229596]
It was reported patient underwent total hip arthroplasty on (b)(6) 2007. A subsequent revision was performed on (b)(6) 2013 due to unknown reasons. While the surgeon was attempting to remove the head with a mallet, the head became cold welded to the stem resulting in a delay of over two hours.
Patient Sequence No: 1, Text Type: D, B5
[20583438]
Current information indicates the use of incorrect instrumentation caused the event. The product identification necessary to review manufacturing history was not provided. There are warnings in the associated package insert that state that this type of event can occur: under precautions it states, "surgical instruments should only be used for their intended purpose. " this report is number 2 of 2 mdrs filed for this event (reference 1825034-2013-01508 & 01524).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-01524 |
| MDR Report Key | 3114390 |
| Report Source | 07 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-04-16 |
| Date Mfgr Received | 2013-04-16 |
| Date Added to Maude | 2013-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGIE DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLET |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | EKD |
| Date Received | 2013-05-15 |
| Model Number | N/A |
| Catalog Number | UNKNOWN MALLET |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-05-15 |